Interpretations of Studies on SARS-CoV-2 Vaccination and Post-acute COVID-19 Sequelae.

This article discusses causal interpretations of epidemiologic studies of the effects of vaccination on sequelae after acute severe acute respiratory syndrome coronavirus 2 infection. To date, researchers have tried to answer several different research questions on this topic. While some studies assessed the impact of postinfection vaccination on the presence of or recovery from post-acute coronavirus disease 2019 syndrome, others quantified the association between preinfection vaccination and postacute sequelae conditional on becoming infected. However, the latter analysis does not have a causal interpretation, except under the principal stratification framework-that is, this comparison can only be interpreted as causal for a nondiscernible stratum of the population. As the epidemiology of coronavirus disease 2019 is now nearly entirely dominated by reinfections, including in vaccinated individuals, and possibly caused by different Omicron subvariants, it has become even more important to design studies on the effects of vaccination on postacute sequelae that address precise causal questions and quantify effects corresponding to implementable interventions.

Response of Unvaccinated US Adults to Official Information About the Pause in Use of the Johnson & Johnson-Janssen COVID-19 Vaccine: Cross-Sectional Survey Study.

Using a rapid response web-based survey, we identified gaps in public understanding of the Centers for Disease Control and Prevention's messaging about the pause in use of the Johnson & Johnson-Janssen COVID-19 vaccine and estimated changes in vaccine hesitancy using counterfactual questions.

What the SARS-CoV-2 Pandemic Has Taught Us About Immunosuppression, Vaccinations, and Immune Dysregulation: The Rheumatology Experience.

PURPOSE OF REVIEW: This review reflects on the impact of the COVID-19 pandemic on the field of rheumatology, emphasizing resulting insights related to the risks of viral infections in immunosuppressed patients, vaccine immunogenicity in immunocompromised patients, and immune dysregulation in the setting of viral infection. RECENT FINDINGS: During the pandemic, global patient registries provided real-time insights into the risk factors associated with severe COVID-19 outcomes in rheumatology patients. Updated evidence-based recommendations from the American College of Rheumatology (ACR) guided rheumatology practice during a time of considerable uncertainty. Studies on COVID-19 vaccines in immunocompromised populations enhanced our understanding of specific immunosuppressive therapies on vaccine efficacy. The immune dysregulation seen in severe COVID-19 underscored a role for immunomodulation in this and other severe infections. Furthermore, novel post-infectious conditions, namely multisystem inflammatory syndrome in children (MIS-C) and Long COVID, reshaped our understanding of post-viral syndromes and revealed novel pathological mechanisms. Lessons from the COVID-19 pandemic demonstrate the power of collaborative research. The scientific revelations from this dreadful time will, nonetheless, benefit the practice of rheumatology for years to come.

Incidence and outcome of COVID-19 following vaccine and hybrid immunity in patients on immunosuppressive therapy: identification of protective post-immunisation anti-RBD antibody levels in a prospective cohort study.

OBJECTIVES: To assess incidence, severity and predictors of COVID-19, including protective post-vaccination levels of antibodies to the receptor-binding domain of SARS-CoV-2 spike protein (anti-RBD), informing further vaccine strategies for patients with immune-mediated inflammatory diseases (IMIDs) on immunosuppressive medication. METHODS: IMIDs on immunosuppressives and healthy controls (HC) receiving SARS-CoV-2 vaccines were included in this prospective observational study. COVID-19 and outcome were registered and anti-RBD antibodies measured 2-5 weeks post-immunisation. RESULTS: Between 15 February 2021 and 15 February 2023, 1729 IMIDs and 350 HC provided blood samples and self-reported COVID-19. The incidence of COVID-19 was 66% in patients and 67% in HC, with re-infection occurring in 12% of patients. Severe COVID-19 was recorded in 22 (2%) patients and no HC. No COVID-19-related deaths occurred. Vaccine-induced immunity gave higher risk of COVID-19 (HR 5.89 (95% CI 4.45 to 7.80)) than hybrid immunity. Post-immunisation anti-RBD levels <6000 binding antibody units/mL were associated with an increased risk of COVID-19 following three (HR 1.37 (95% CI 1.08 to 1.74)) and four doses (HR 1.28 (95% CI 1.02 to 1.62)), and of COVID-19 re-infection (HR 4.47 (95% CI 1.87 to 10.67)). CONCLUSION: Vaccinated patients with IMID have a low risk of severe COVID-19. Hybrid immunity lowers the risk of infection. High post-immunisation anti-RBD levels protect against COVID-19. These results suggest that knowledge on COVID-19 history, and assessment of antibody levels post-immunisation can help individualise vaccination programme series in high-risk individuals. TRIAL REGISTRATION NUMBER: NCT04798625.

Perceptions of Racial-Ethnic Inequities in COVID-19 Healthcare and Willingness to Receive the COVID-19 Vaccine.

BACKGROUND: Perceptions of the US healthcare system can impact individuals' healthcare utilization, including vaccination intentions. This study examined the association between perceived racial-ethnic inequities in COVID-19 healthcare and willingness to receive the COVID-19 vaccine. METHODS: This study used data from REACH-US, a nationally representative online survey of a large, diverse sample of U.S. adults (N=5145 January 26, 2021-March 3, 2021). Confirmatory factor and regression analyses examined a latent factor of perceived racial-ethnic inequities in COVID-19 healthcare, whether the factor was associated with willingness to receive the COVID-19 vaccine, and whether associations varied across racial-ethnic groups reported as probit estimates (B) and 95% confidence intervals (CIs). RESULTS: Perceived racial-ethnic inequities in COVID-19 healthcare were highest among Black/African American adults (mean latent factor score: 0.65 ± 0.43) and lowest among White adults (mean latent factor score: 0.04 ± 0.67). Black/African American (B = -0.08; 95% CI = -0.19, 0.03) and Native Hawaiian/Pacific Islander (B = -0.08; 95% CI = -0.23, 0.07) adults who perceived greater racial-ethnic inequities in COVID-19 healthcare were less willing than participants who perceived lower inequities. In contrast, American Indian/Alaska Native (B = 0.15; 95% CI = -0.01, 0.30), Asian (B = 0.20; 95% CI = 0.08, 0.31), Hispanic/Latino (English language preference) (B = 0.22; 95% CI = 0.01, 0.43), Multiracial (B = 0.23; 95% CI = 0.09, 0.36), and White (B = 0.31; 95% CI = 0.19, 0.43) adults who perceived greater racial-ethnic inequities in COVID-19 healthcare were more willing to receive the COVID-19 vaccine than participants perceiving higher inequities. CONCLUSIONS: Greater perceived racial-ethnic inequities in COVID-19 healthcare were associated with less willingness to receive the COVID-19 vaccine among Black/African American and Native Hawaiian/Pacific Islander adults.

Racial/ethnic differences in the associations between trust in the U.S. healthcare system and willingness to test for and vaccinate against COVID-19.

BACKGROUND: Trust in the healthcare system may impact adherence to recommended healthcare practices, including willingness to test for and vaccinate against COVID-19. This study examined racial/ethnic differences in the associations between trust in the U.S. healthcare system and willingness to test for and vaccinate against COVID-19 during the first year of the pandemic. METHODS: This cross-sectional study used data from the REACH-US study, a nationally representative online survey conducted among a diverse sample of U.S. adults from January 26, 2021-March 3, 2021 (N = 5,121). Multivariable logistic regression estimated the associations between trust in the U.S. healthcare system (measured as "Always", "Most of the time", "Sometimes/Almost Never", and "Never") and willingness to test for COVID-19, and willingness to receive the COVID-19 vaccine. Racial/ethnic differences in these associations were examined using interaction terms and multigroup analyses. RESULTS: Always trusting the U.S. healthcare system was highest among Hispanic/Latino Spanish Language Preference (24.9%) and Asian (16.7%) adults and lowest among Multiracial (8.7%) and Black/African American (10.7%) adults. Always trusting the U.S. healthcare system, compared to never, was associated with greater willingness to test for COVID-19 (AOR: 3.20, 95% CI: 2.38-4.30) and greater willingness to receive the COVID-19 vaccine (AOR: 2.68, 95% CI: 1.97-3.65). CONCLUSIONS: Trust in the U.S. healthcare system was associated with greater willingness to test for COVID-19 and receive the COVID-19 vaccine, however, trust in the U.S. healthcare system was lower among most marginalized racial/ethnic groups. Efforts to establish a more equitable healthcare system that increases trust may encourage COVID-19 preventive behaviors.

A CROSS-SECTIONAL STUDY ON COVID-19 VACCINATION HESITATION AMONG UNIVERSITY STUDENTS.

Students serve as ambassadors, conveying effective messages to encourage the adoption of promotes healthy behaviors. Recognizing their consciousness about corona illness 2019 (COVID-19), desires to utilize the COVID-19 vaccines, and other associated variables will aid in developing viable vaccination promotion tactics for the present COVID-19 pandemic. A transverse-segment internet poll of university students in the healthcare and non-healthcare industries was conducted to analyze their motivations to be vaccinated against the coronavirus. To recruit research participants, a random snowball sampling approach was utilized using digital media sites and mails. The contestants were chosen from throughout India, including several main geographic areas, between Nov-2020 and Jan-2021, prior to the release of the COVID-19 vaccination. There were descriptive metrics utilized to illustrate the research participants' socio-demographics and vaccine-related behaviors. Using logistic regression modeling, key characteristics that are expected to influence vaccination uptake among students were modeled. p 0.06 was judged substantial in each study. 656 students participated in the study, with 48.4% coming from the healthcare sector & 51.5% from other fields. Of these 655 students, 43.6 and 22.4% came from India's northern and eastern areas. Graduate students accounted for 41.1% of the total population, and graduates for around 43.2%. The age range of 56.0% of the students was 18 to 25. Women made up 62% of the population, and 69.5% of them were unmarried. Seventy-eight percent of the students were from the medium socioeconomic level. Concerns about side effects and safety, distrust of government officials, and questions about the vaccine's efficacy were among the reasons given by students in this study for their reluctance to get vaccinated. It is essential to remember that these investigations were carried out at various times and in various nations; thus, the conclusions may not apply to all college students throughout the globe. According to the findings of this research, Indian university students showed rather a great deal of motivating desire to acquire COVID-19 immunizations. The people were either doubtful or reluctant to get the vaccination, which suggests possible vaccine aversion. There is a need for information campaigns and other actions to lessen vaccine hesitancy in order to promote the usage of COVID-19 vaccines.

Review of COVID-19 Therapeutics by Mechanism: From Discovery to Approval.

The global research and pharmaceutical community rapidly mobilized to develop treatments for coronavirus disease 2019 (COVID-19). Existing treatments have been repurposed and new drugs have emerged. Here we summarize mechanisms and clinical trials of COVID-19 therapeutics approved or in development. Two reviewers, working independently, reviewed published data for approved COVID-19 vaccines and drugs, as well as developmental pipelines, using databases from the following organizations: United States Food and Drug Administration (US-FDA), European Medicines Agency (EMA), Japanese Pharmaceutical and Medical Devices Agency (PMDA), and ClinicalTrials.gov. In all, 387 drugs were found for initial review. After removing unrelated trials and drugs, 66 drugs were selected, including 17 approved drugs and 49 drugs under development. These drugs were classified into six categories: 1) drugs targeting the viral life cycle 2) Anti-severe acute respiratory syndrome coronavirus 2 Monoclonal Antibodies, 3) immunomodulators, 4) anti-coagulants, 5) COVID-19-induced neuropathy drugs, and 6) other therapeutics. Among the 49 drugs under development are the following: 6 drugs targeting the viral life cycle, 12 immunosuppression drugs, 2 immunostimulants, 2 HIF-PHD targeting drugs, 3 GM-CSF targeting drugs, 5 anti-coagulants, 2 COVID-19-induced neuropathy drugs, and 17 others. This review provides insight into mechanisms of action, properties, and indications for COVID-19 medications.

Nirmatrelvir for Vaccinated or Unvaccinated Adult Outpatients with Covid-19.

BACKGROUND: Nirmatrelvir in combination with ritonavir is an antiviral treatment for mild-to-moderate coronavirus disease 2019 (Covid-19). The efficacy of this treatment in patients who are at standard risk for severe Covid-19 or who are fully vaccinated and have at least one risk factor for severe Covid-19 has not been established. METHODS: In this phase 2-3 trial, we randomly assigned adults who had confirmed Covid-19 with symptom onset within the past 5 days in a 1:1 ratio to receive nirmatrelvir-ritonavir or placebo every 12 hours for 5 days. Patients who were fully vaccinated against Covid-19 and who had at least one risk factor for severe disease, as well as patients without such risk factors who had never been vaccinated against Covid-19 or had not been vaccinated within the previous year, were eligible for participation. Participants logged the presence and severity of prespecified Covid-19 signs and symptoms daily from day 1 through day 28. The primary end point was the time to sustained alleviation of all targeted Covid-19 signs and symptoms. Covid-19-related hospitalization and death from any cause were also assessed through day 28. RESULTS: Among the 1296 participants who underwent randomization and were included in the full analysis population, 1288 received at least one dose of nirmatrelvir-ritonavir (654 participants) or placebo (634 participants) and had at least one postbaseline visit. The median time to sustained alleviation of all targeted signs and symptoms of Covid-19 was 12 days in the nirmatrelvir-ritonavir group and 13 days in the placebo group (P = 0.60). Five participants (0.8%) in the nirmatrelvir-ritonavir group and 10 (1.6%) in the placebo group were hospitalized for Covid-19 or died from any cause (difference, -0.8 percentage points; 95% confidence interval, -2.0 to 0.4). The percentages of participants with adverse events were similar in the two groups (25.8% with nirmatrelvir-ritonavir and 24.1% with placebo). In the nirmatrelvir-ritonavir group, the most commonly reported treatment-related adverse events were dysgeusia (in 5.8% of the participants) and diarrhea (in 2.1%). CONCLUSIONS: The time to sustained alleviation of all signs and symptoms of Covid-19 did not differ significantly between participants who received nirmatrelvir-ritonavir and those who received placebo. (Supported by Pfizer; EPIC-SR ClinicalTrials.gov number, NCT05011513.).

Implementation of COVID-19 vaccination services in prison in six European countries: translating emergency intervention into routine life-course vaccination.

BACKGROUND: Evidence has shown that the risk of transmission of SARS-CoV-2 is much higher in prisons than in the community. The release of the COVID-19 vaccine and the recommendation by WHO to include prisons among priority settings have led to the inclusion of prisons in national COVID-19 vaccination strategies. Evidence on prison health and healthcare services provision is limited and often focuses on a single country or institution due to the multiple challenges of conducting research in prison settings. The present study was done in the framework of the EU-founded project RISE-Vac. It aimed to analyse the best practices and challenges applied in implementing COVID-19 universal vaccination services during the pandemic to support future expansion of routine life course vaccination services for people living in prison (PLP). METHODS: Two online cross-sectional surveys were designed and piloted: survey1 on prison characteristics and (non-COVID-19) immunisation practices; survey2 on the implementation and coverage of COVID-19 vaccination with open-ended questions for thematic analysis. Each RISE-Vac project partner distributed the questionnaire to one or two prisons in their country. Answers were collected from eight European prisons' directors or medical directors between November 2021-May 2022. RESULTS: According to our findings, the implementation modalities of COVID-19 vaccination services in the surveyed prisons were effective in improving PLP vaccination coverage. Strategies for optimal management of the vaccination campaign included: periodic time slot for PLP vaccination; new staff recruitment and task shifting; distribution of informational material both to PLP and prison staff. Key challenges included continuity of care after release, immunisation information system, and vaccine hesitancy. CONCLUSIONS: To the best of our knowledge, this is the first study describing the implementation of COVID-19 vaccination services in European prisons, suggesting that the expansion of vaccination provision in prison is possible. There is no unique solution that will fit every country but commonalities likely to be important in the design and implementation of future vaccination campaigns targeting PLP emerged. Increased availability of vaccination services in prison is not only possible, but feasible and highly desirable, and can contribute to the reduction of health inequalities.

Reaching Diverse Communities During a Local Public Health COVID-19 Vaccination Response Through a Mobile Clinic Compared to Mass Vaccination Sites.

During the COVID-19 vaccine rollout, local public health agencies were responsible for vaccinating a wide variety of communities. Dakota County Public Health (Dakota County, Minnesota) implemented a program that offered COVID-19 vaccines in a variety of settings, such as county public health buildings, community sites, in-home, mass vaccination clinics, and a mobile clinic unit. The purpose of this analysis is to compare the demographics of vaccinations administered at Dakota County COVID-19 vaccination clinics based on clinic site. More than half (52.5%) of vaccinations administered at mobile clinic sites were administered to Hispanic or Latino clients, while at the mass vaccination clinic site, 5.4% of vaccinations were administered to Hispanic or Latino clients. In addition, 59.6% of in-home vaccinations were administered to adults 65 years and older. Offering COVID-19 vaccination clinics in a variety of clinic settings strategically throughout the community helped increase vaccine reach to diverse communities.

The level of knowledge and acceptance towards the COVID-19 vaccine among the community in Johor Bahru, Johor.

INTRODUCTION: Several necessary initiatives have been made to create a readily available vaccine against the Coronavirus Disease 2019 (COVID-19) worldwide pandemic. However, the vaccination program's success is dependent on the population's willingness as well as their knowledge of vaccination. Hence, the present study aimed to assess the level of knowledge and acceptance towards the COVID-19 vaccine among the community in Johor Bahru, Johor. MATERIALS AND METHODS: A cross-sectional study was conducted using an online survey between February and May 2022, with 423 respondents. The questionnaire consisted of socio-demographic, assessment of knowledge level and acceptance level towards COVID-19 vaccine. The descriptive analysis and non-parametric tests were employed to investigate the study outline objectives. RESULTS: Of all 423 participants, 293 (69.3%) of the participants had a high level of knowledge about the COVID- 19 vaccine (median knowledge score 6; IQR = 3), and 239 (56.5%) were reported to have a low level of vaccine acceptance (median acceptance scores 4; IQR=2). The knowledge level towards the COVID-19 vaccine was significantly associated with the vaccine acceptance level (p<0.001). CONCLUSION: The community's level of knowledge towards COVID-19 vaccine was high; however, the vaccine acceptance was low.

In silico clinical studies for optimal COVID-19 vaccination schedules in patients with cancer.

This study introduces a tailored COVID-19 model for patients with cancer, incorporating viral variants and immune-response dynamics. The model aims to optimize vaccination strategies, contributing to personalized healthcare for vulnerable groups.

Current German Recommendations and International Research on the Use of COVID-19 Boosters among Health Care Providers in 2024: A Narrative Review.

While the World Health Organization (WHO) has de-escalated coronavirus disease 2019 (COVID-19) from a global health emergency, ongoing discussions persist as new viral variants. This article aimed to consolidate German recommendations and international research to offer health care providers (HCPs) a comprehensive guide on COVID-19 boosters in 2024. The review outlines key recommendations from the German Robert Koch Institute. HCPs should receive COVID-19 boosters at least 12 months after their last vaccination or COVID-19 infection, contingent on the prevalent viral variant(s) in the region. However, excessive doses and/or frequent boosters, especially with mRNA vaccines, may lead to immune imprinting, T-cell exhaustion, and immunoglobulin (Ig) switching. Notably, this review highlights the significance of Ig, particularly IgA and IgG subclasses, in influencing infection risk and disease progression. Furthermore, it explores the implications of mRNA vaccine technology and potential adverse effects related to excessive dosing. In conclusion, this article provides a comprehensive analysis of COVID-19 vaccine boosters for HCPs, synthesising current recommendations, scientific debates, and considerations for optimising protection against SARS-CoV-2 in the evolving landscape of the post-pandemic era.

The humoral immune response to the BNT 162B2 vaccine in pediatrics on renal replacement therapy.

INTRODUCTION: Since the start of the COVID-19 pandemic, data published on the immunogenicity of the SARS-CoV-2 BNT 162B2 vaccine in pediatric patients receiving renal replacement therapy are scant. Our primary objective is to study this population's humoral immune response to the COVID-19 vaccine. METHODS: Pediatric kidney transplant recipients (PKTRs) and hemodialysis recipients (HR) at our center who received two doses of the SARS-CoV-2 BNT 162B2 vaccine were included. Transplant and HR who had PCR-positive COVID-19 infections during the study, regardless of their vaccine status, were also included. SARS-CoV-2 anti-spike protein (S1/S2) IgG was measured after the second dose of the vaccine and after any PCR-positive COVID-19 infection as routine clinical practice. Data on demographics, induction, maintenance immunosuppressants, type of transplant, and posttransplant or dialysis duration were included. RESULTS: Of the 61 patients included, 19 were dialysis recipients who received two doses of vaccine without subsequent infection (HV), and 42 were kidney transplant recipients. All dialysis patients and 33 (78.6%) transplant recipients received two doses of the SARS-CoV-2 BNT 162b2 vaccine. A total of 33.3% (11/33) of the transplant recipients who received vaccination developed COVID-19 infection (KTH) at a median time of 13 days after the second dose of vaccine. Nine transplant patients had pure COVID-19 infection without vaccination (KTI). The seroconversion rate in the HV group was 94.7% (18/19) compared to 50% (11/22) in the kidney transplant vaccine recipients who did not develop subsequent COVID-19 infection (KTV) (p < .001). The median S1/S2 IgG titers for the HV group were 400 AU/mL versus 15 AU/mL in the KTV group (p < .0001). There was no significant difference in the duration of the test from the second dose of the vaccine between HV and KTV (55 vs. 33.5 days, p = .095). The KTH had higher titers than KTV group (370 vs. 15 p < .0001). The median duration of the test after vaccination in the vaccine group and those with hybrid immunity was similar (35 vs. 33.5 days, p = .2).There were no clear predictors for seroconversion in the PKTRs. Natural infection alone was as good as the vaccine in eliciting humoral immune response. CONCLUSION: The humoral immune response to two doses of the SARS-CoV-2 BNT 162B2 vaccine in PKTRs without subsequent COVID-19 infection is suboptimal compared to that in hemodialysis recipients and in PKTRs with hybrid immunity from both infection and vaccination.

Breakthrough SARS-CoV-2 infection and disease flares in patients with rheumatoid arthritis: result from COVAD e-survey study.

COVID-19 has been suggested as a possible trigger of disease flares in patients with rheumatoid arthritis (RA). However, factors associated with disease flares remain unknown. This study aimed to identify factors associated with breakthrough infection (BIs) and disease flares in patients with RA following COVID-19. We analysed data from RA patients who participated in the COVID-19 vaccination in autoimmune diseases (COVAD) study. Demographic data, patient-reported outcomes, comorbidities, pharmacologic treatment and details regarding disease flares were extracted from the COVAD database. Factors associated with disease flare-ups were determined by multivariate logistic regression analysis. The analysis comprised 1928 patients with RA who participated in the COVAD study. Younger age, Caucasian ethnicity, comorbidities with obstructive chronic pulmonary disease and asthma were associated with COVID-19 breakthrough infection. Moreover, younger age (odds ratio (OR): 0.98, 95% CI 0.96-0.99, p < 0.001), ethnicity other than Asian, past history of tuberculosis (OR: 3.80, 95% CI 1.12-12.94, p = 0.033), treatment with methotrexate (OR: 2.55, 95% CI: 1.56-4.17, p < 0.001), poor global physical health (OR: 1.07, 95% CI 1.00-1.15, p = 0.044) and mental health (OR: 0.91, 95% CI 0.87-0.95, p < 0.001) were independent factors associated disease flares in patients with RA. Our study highlights the impact of socio-demographic factors, clinical characteristics and mental health on disease flares in patients with RA. These insights may help determine relevant strategies to proactively manage RA patients at risk of flares.

Validation of the questionnaire "Pregnancy Vaccine Hesitancy Scale (pVHS)" toward COVID-19 vaccine for Malaysian pregnant women.

Background: Pregnancy is one of the risks for severe COVID-19 infection, and receiving a vaccination is one of the effective methods to reduce disease severity. However, COVID-19 vaccine hesitancy among pregnant women remains an issue. This study aims to develop and validate the pregnancy Vaccine Hesitancy Scale (pVHS) toward COVID-19 vaccine for Malaysian pregnant women. Method: An 8-item Malay language pregnancy Vaccine Hesitancy Scale (pVHS-M) for COVID-19 was adapted from the adult Vaccine Hesitancy Scale and validated using Exploratory Factor Analysis. Six expert panels were involved in content validity, and ten pregnant women were involved in face validity. A cross-sectional study on 200 pregnant women was conducted between October 2022 and March 2023 at the Obstetrics and Gynaecology Clinic, Universiti Sains Malaysia, Kelantan. Result: The item-level content validity index is 1.00, demonstrating good relevance of the eight items used to assess COVID-19 vaccine hesitancy. The item-level face validity index obtained is 0.99, indicating that the items were clear and comprehensible. The Cronbach alpha score was 0.944, with factor loadings ranging from 0.79 to 0.89. Conclusion: The pVHS-M demonstrated good internal consistency, indicating that it is a valid and reliable tool for assessing COVID-19 vaccine hesitancy among pregnant women.

Effectiveness of the SARS-CoV-2 Vaccination in Preventing Severe Disease-Related Outcomes: A Population-Based Study in the Italian Province of Bolzano (South Tyrol).

Objective: To investigate the effectiveness of SARS-CoV2 vaccination in preventing ordinary or intensive care unit (ICU) admissions and deaths among cases registered during a variant transitional pandemic phase in the geographically and culturally unique territory of the Province of Bolzano (South Tyrol), an Italian region with low vaccination coverage. Methods: We collected data from 93,643 patients registered as positive for SARS-CoV-2 by health authorities during the winter of 2021-22. The data were analyzed retrospectively using descriptive statistics and multiple logistic regression. Results: 925 patients were hospitalized (0.99%), 89 (0.10%) were in intensive care, and 194 (0.21%) died. Vaccinated patients had a significantly lower risk of being hospitalized: adjusted Odds Ratio (aOR): 0.39; 95% CI: 0.33-0.46, ICU admission: aOR: 0.16; 95% CI: 0.09-0.29 and death: aOR: 0.41; 95% CI: 0.29-0.58. Similar risk reductions were also observed in booster-vaccinated patients, independent of sex, age, and predominant variant. Furthermore, the median length of stay (LoS) in the ICU was significantly longer for unvaccinated individuals compared to vaccinated subjects (9 vs. 6 days; p < 0.003). Conclusion: Primary series vaccination and ongoing campaign booster doses were effective in preventing all severe disease-related outcomes and in reducing ICU Length of Stay, even during a transitional pandemic phase and in a unique territorial context.

Stroke Risk After COVID-19 Bivalent Vaccination Among US Older Adults.

Importance: In January 2023, the US Centers for Disease Control and Prevention and the US Food and Drug Administration noted a safety concern for ischemic stroke among adults aged 65 years or older who received the Pfizer-BioNTech BNT162b2; WT/OMI BA.4/BA.5 COVID-19 bivalent vaccine. Objective: To evaluate stroke risk after administration of (1) either brand of the COVID-19 bivalent vaccine, (2) either brand of the COVID-19 bivalent plus a high-dose or adjuvanted influenza vaccine on the same day (concomitant administration), and (3) a high-dose or adjuvanted influenza vaccine. Design, Setting, and Participants: Self-controlled case series including 11 001 Medicare beneficiaries aged 65 years or older who experienced stroke after receiving either brand of the COVID-19 bivalent vaccine (among 5 397 278 vaccinated individuals). The study period was August 31, 2022, through February 4, 2023. Exposures: Receipt of (1) either brand of the COVID-19 bivalent vaccine (primary) or (2) a high-dose or adjuvanted influenza vaccine (secondary). Main Outcomes and Measures: Stroke risk (nonhemorrhagic stroke, transient ischemic attack, combined outcome of nonhemorrhagic stroke or transient ischemic attack, or hemorrhagic stroke) during the 1- to 21-day or 22- to 42-day risk window after vaccination vs the 43- to 90-day control window. Results: There were 5 397 278 Medicare beneficiaries who received either brand of the COVID-19 bivalent vaccine (median age, 74 years [IQR, 70-80 years]; 56% were women). Among the 11 001 beneficiaries who experienced stroke after receiving either brand of the COVID-19 bivalent vaccine, there were no statistically significant associations between either brand of the COVID-19 bivalent vaccine and the outcomes of nonhemorrhagic stroke, transient ischemic attack, nonhemorrhagic stroke or transient ischemic attack, or hemorrhagic stroke during the 1- to 21-day or 22- to 42-day risk window vs the 43- to 90-day control window (incidence rate ratio [IRR] range, 0.72-1.12). Among the 4596 beneficiaries who experienced stroke after concomitant administration of either brand of the COVID-19 bivalent vaccine plus a high-dose or adjuvanted influenza vaccine, there was a statistically significant association between vaccination and nonhemorrhagic stroke during the 22- to 42-day risk window for the Pfizer-BioNTech BNT162b2; WT/OMI BA.4/BA.5 COVID-19 bivalent vaccine (IRR, 1.20 [95% CI, 1.01-1.42]; risk difference/100 000 doses, 3.13 [95% CI, 0.05-6.22]) and a statistically significant association between vaccination and transient ischemic attack during the 1- to 21-day risk window for the Moderna mRNA-1273.222 COVID-19 bivalent vaccine (IRR, 1.35 [95% CI, 1.06-1.74]; risk difference/100 000 doses, 3.33 [95% CI, 0.46-6.20]). Among the 21 345 beneficiaries who experienced stroke after administration of a high-dose or adjuvanted influenza vaccine, there was a statistically significant association between vaccination and nonhemorrhagic stroke during the 22- to 42-day risk window (IRR, 1.09 [95% CI, 1.02-1.17]; risk difference/100 000 doses, 1.65 [95% CI, 0.43-2.87]). Conclusions and Relevance: Among Medicare beneficiaries aged 65 years or older who experienced stroke after receiving either brand of the COVID-19 bivalent vaccine, there was no evidence of a significantly elevated risk for stroke during the days immediately after vaccination.